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The Dangers Of Off-Label Drug Use

posted by Alicia Caramenico

on November 4, 2015

Ensuring patients are receiving safe, effective, and efficient care is paramount to health plans. But a new article in the Journal of the American Medical Association (JAMA) shows that is rarely the case when it comes to off-label use of prescription drugs.

Off-label use – prescribing medications for health conditions or treatments other than what the FDA has approved –  has risen dramatically in recent years. But too often there’s little or no scientific support for such use. Off-label utilization of particular drugs can lead to serious side effects, complications, and adverse events.

The JAMA article is the first study to evaluate the association between real-life off-label prescription drug use and adverse health events. It found four in five prescriptions lacked strong scientific evidence to support off-label use of a drug, leading to higher rates of adverse effects.

Journalist Steven Brill also has sounded the alarm on the dangers of off-label uses with no scientific validity. He cites how Johnson & Johnson encouraged doctors to prescribe an anti-psychotic drug to children and the elderly in violation of FDA restrictions, who then suffered serious health reactions.

This all points to a need for appropriate safeguards to make sure information provided to physicians is based on sound evidence and is unbiased.  And with greater transparency, we can promote the safe and effective use of products while protecting our patients.

Because most patients don’t know when they are receiving a drug off label, health plans have utilization management policies in place to ensure the appropriate and safe use of medications, as well criteria for when off-label use of a drug may be considered medically necessary. These tools are an important part of protecting patients from harmful or ineffective treatment.